Status:
COMPLETED
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.
Detailed Description
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's Laboratories Ltd.,) with Pri...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who provided written informed consent.
- Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
- Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
- Subjects with normal ECG, chest X-ray (PA view) and vital signs.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- Test product, dose, mode of administration and batch number
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01170169
Start Date
January 1 2006
End Date
March 1 2006
Last Update
July 27 2010
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